Multi-parametric MRI/Fluorine-18 Fluciclovine PET-CT in Glioblastoma

August 2, 2019 updated by: The Leeds Teaching Hospitals NHS Trust

Glioblastoma is the most common adult brain tumour with approximately 2000 new cases each year in the UK.

Optimal treatment consists of surgery followed by radiotherapy and chemotherapy but despite this survival is poor with only 10% of patients alive at 5 years.

Standard imaging (MRI and CT) may not detect the full extent of tumours before treatment and it can be difficult to assess how the tumour is responding to treatment.

The study aims to evaluate more advanced imaging techniques to see if they are better at mapping the whole tumour and assessing response to treatment. Two different imaging techniques will be assessed: Positron Emission Tomography - Computed Tomography (PET-CT) uses a mildly radioactive compound injected into the patient which is taken up into brain tumour cells and shows up as a bright spot on scans. Brain tumours affect blood supply and how much fluid is in the brain tissue as well as how freely fluid can move around. Advanced MR imaging known as multiparametric MRI will be used to look at these additional features. This extra information may help improve planning of radiotherapy and assessing how tumours respond to treatment. Twelve adult patients with glioblastoma undergoing radical treatment will be recruited over a 12 month period. Each patient will have standard MR imaging before radiotherapy (after surgery) and 4-6 weeks following completion of radiotherapy. They will also have advanced MRI and PET/CT before, during and after treatment.

The aim will be to study if this is feasible and could potentially improve radiotherapy planning and response assessment. Imaging will be interpreted by both imaging and brain tumour treatment experts.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • Department of Nuclear Medicine, St James's University Hospitals
        • Contact:
          • Andrew Scarsbrook

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Twelve adult patients with glioblastoma undergoing radical treatment will be recruited

Description

Inclusion Criteria:

  • Age ≥18
  • WHO Performance status 0-2 (Appendix 1)
  • Histologically proven GBM (WHO Grade 4)
  • Clinical decision made to proceed with radical treatment with surgery and chemo-radiotherapy
  • Residual tumour following surgery as defined by the surgeons at the time of resection
  • Able to provide fully informed written consent
  • Able to lie flat for 1 hour
  • Not be pregnant or breast feeding. Female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be post-menopausal.

Exclusion Criteria:

Patients with any of the following are not eligible for the study:

  1. Hypersensitivity to Fluorine-18 Fluciclovine
  2. Hypersensitivity to MRI contrast media
  3. Acute renal failure or moderate renal impairment (estimated glomerular filtration rate < 30 mL/min)
  4. Claustrophobia precluding imaging
  5. Non-MRI compatible implantable device e.g. pacemaker
  6. Uncontrolled pain
  7. Urinary incontinence
  8. Female patients must not be pregnant and if of child bearing age using adequate contraception
  9. Breast feeding
  10. Serious psychiatric co-morbidity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurment od tumour volumes following scans
Time Frame: 6 months
The patients tumour volumes from conventional MR, advanced MR and PET/CT will be the primary outcome measure.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Anticipated)

October 31, 2020

Study Completion (Anticipated)

October 31, 2020

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (Actual)

January 24, 2018

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 2, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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